Explanatory Memorandum to COM(2013)892 - Cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes - Main contents
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| dossier | COM(2013)892 - Cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes. |
|---|---|
| source | COM(2013)892  |
| date | 18-12-2013 |
Cloning is a relatively new technique of asexual reproduction of animals producing near exact genetic copies of the animal cloned, i.e. without modification of genes.
In food production cloning is a new technique. Hence, under the current legislative framework, food from clones falls under the scope of the Novel Food Regulation i and is thus subject to pre-market approval based on a food safety risk assessment.
In 2008 the Commission presented a proposal[2] to streamline the approval process in the Novel Food Regulation. In the legislative procedure lawmakers aimed to amend the proposal to introduce specific rules on cloning[3]. Yet no agreement was reached on the scope and features of these insertions so that the proposal was abandoned after a failed Conciliation in March 2011. As a result the Commission was asked to prepare a legislative proposal on cloning in food production based on an impact assessment outside the Novel Food Regulation i.
The European Food Safety Authority (EFSA) views cloning primarily as an animal welfare hazard related to the low efficiency of the technique. It up-dated its opinion on cloning of animals in 2012[5] concluding that scientific knowledge available on cloning has increased but that nevertheless its efficiency remains low compared to other reproduction techniques.
The objective of this proposal is to ensure uniform conditions of production for farmers while protecting the health and welfare of animals.
Directive 98/58/EC[6] on the protection of animals kept for farming purposes sets very general minimum animal welfare standards for animals used in agriculture. It does not refer explicitly to cloning, but calls on Member States to avoid unnecessary pain, suffering or injury in farm animals. If cloning causes unnecessary pain, suffering or injury Member States have to act at national level to avoid it.
This initiative responds to the above-mentioned concerns while avoiding unnecessary burdens for farmers and breeders established in the Union and in third countries.
The proposal envisages a suspension on Union territory of:
• the use of the technique for food production purposes;
• the marketing of live clones (animal clones).
These provisional prohibitions will confine a production technique causing distress to animals to areas where it appears to have particular benefit.
The provisional prohibitions are kept under review given the development of knowledge on the technique and progress in the application of the technique in areas outside farming.
This initiative excludes cloning carried out in research, for the preservation of rare breeds or endangered species and for the production of medicinal products and medical devices.
Contents
- RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENT
- LEGAL ELEMENTS OF THE PROPOSAL
- BUDGETARY IMPLICATION
- 1.1. Background of the proposal
- 1.2. Objectives of the proposal
- 1.3. Regulatory framework
- 1.4. Consistency with other policies and objectives of the Union
- 2.1. Consultation process
- 2.1.1. Consultation methods and main sectors targeted
- 2.1.2. Summary of responses and how they have been taken into account
- 2.1.3. External expertise
- 3.1. Legal basis
- 3.2. Subsidiarity principle
- 3.3. Proportionality principle
- 3.4. Choice of instruments
Member States, stakeholders and third country trade partners were consulted.
The Standing Committee for the Food Chain and Animal Health was the main forum for discussions with Member States. In addition all Member States completed a specific questionnaire on cloning on their territory.
Stakeholders were consulted in the Advisory Group of the Food Chain. Twenty-two organisations representing all sectors concerned (farmers, breeders, food industry, retailers, consumers and animal rights activists) participated. In addition five technical meetings were held with organisations representing farmers, breeders and the food industry.
A specific questionnaire was sent to the 15 major third country trade partners of which 13 replied.
The general public was consulted via the Interactive Policy Making Initiative in March 2012. This tool reaches approximately 6000 subscribers of which 360 replied[7].
Two Eurobarometer surveys addressed cloning: a 2008 specific survey on cloning[8] performed in 27 Member States and a 2010 survey on biotechnology[9] with specific questions on cloning performed in 27 Member States and 5 non-Union European countries.
The specific report on cloning by the European Group on Ethics in Science and New Technologies (EGE) of 2008[10] expressed doubts that animal cloning for farming purposes can be justified 'considering the current level of suffering and health problems of surrogate dams and animal clones'. The EGE also concluded that it did 'not see convincing arguments to justify the production of food from clones and their offspring'.
Member States confirmed that animals are presently not cloned for faming purposes in the Union. The economic sectors involved (farming and breeding) indicated that they have, at this time, no interest to produce animals for farm purposes though cloning. Farmers and breeders however stressed that to remain competitive they need to have access to high performance genes including the reproductive material of clones.
Argentina, Australia, Brazil, Canada, and the United States confirmed that animals are cloned on their territory but could not indicate to what extent. In Brazil, Canada and United States clones are registered by private companies. In Canada the legal situation on cloning is similar to that in the Union, i.e. food produced from animal clones is considered novel and requires pre-market approval. Argentina, Australia, Brazil, Canada, New Zealand, Paraguay and the United States pointed out that measures should be science-based. They moreover stressed that measures should be no more trade-restrictive than necessary to fulfil legitimate objectives.
Union citizens, on the other hand, held a broadly negative perception of the use of the cloning technique for the production of animals for farming purposes.
This initiative takes account of the results of the consultations. It addresses justified concerns in a proportionate manner and considers the limits of the powers conferred to the Commission by the Treaties. This implies limiting the measures to the animals concerned (i.e. the surrogate mothers and the clones) and the species likely to be cloned (bovine, porcine, caprine, ovine and equine) for farming purposes.
In 2008 the European Food Safety Authority (EFSA) delivered an opinion on cloning. It focused on animal clones, their progeny and of the products obtained from those animals. This opinion was up-dated by three statements in 2009, 2010 and 2012[11]. Based on the available data EFSA saw animal welfare problems related to the health of surrogate mothers (carrying the clones) and the clones themselves. Surrogate dams suffer in particular from placenta dysfunctions contributing to increased levels of miscarriages. This contributes, amongst others, to the low efficiency of the technique (6-15 % for bovine and 6 % for porcine species) and the need to implant embryo clones into several dams to obtain one clone. In addition, clone abnormalities and unusually large offspring result in difficult births and neonatal death. A high mortality rate is a characteristic of the cloning technique. On the other hand EFSA repeatedly stated that cloning has no impact on the safety of meat and milk obtained from the clones.
2.2. Impact assessment[12]
Based on the experience gained in the legislative procedure which failed in March 2011 and the positions expresses by stakeholders, four options were assessed[13]. As a result of the analysis of the four options, and considering their impacts and the objectives pursued, elements of Option 4 (i.e. temporary suspension of the technique and of imports of live clones) were retained as the basis of the present proposal. Suspending the use of the technique and the marketing of animal clones for farming purposes ensures that all Union farmers and breeders are subject to the same conditions while adequately protecting animal welfare. To preserve the competitiveness of Union farmers, the proposal does not regulate reproductive material of clones.
The proposal is based on Article 43 TFEU (agriculture). The objectives of the Union's agricultural policy enumerated in Article 39 TFEU require ensuring, amongst others, the rational development of agricultural production. This implies ensuring uniform conditions of production for farmers. In choosing the means to achieve these objectives, account must also be taken of Article 13 TFEU. Article 13 TFEU requires that in formulating and implementing of, amongst others, the Union's agriculture policy that the Union and the Member States pay full regard to the welfare requirements of animals since they are sentient beings.
Isolated approaches to animal cloning could lead to distortions of the agricultural markets concerned. It is thus necessary to ensure that the same conditions apply and thus to address the matter at Union level.
The suspension of the cloning technique and the suspension of imports of live clones are suitable and necessary measures to achieve the objectives. They also present the best cost-benefit ratio to resolve the issues at stake.
At its present state of development it appears that the use of the cloning technique for farming purposes is of limited benefit. For this reason, this proposal addresses only those aspects related to animal production for farming purposes. It does not cover other areas where cloning can be justified due to a positive risk-benefit ratio (such as research or the use of reproductive material of clones).
The suspension of the cloning technique and of imports of animal clones for farming purposes thus strikes a reasonable fair balance between animal welfare, citizens' concerns and the interests of farmers, breeders and other stakeholders involved.
The proposed instrument is a Directive. Other types of measures would not be appropriate for the following reasons:
(i) a directive allows Member States employ existing control tools as appropriate for the implementation of Union rules and thus to limit the administrative burden;
(ii) soft law instruments are considered insufficient to prevent the use of a technique throughout the Union.
In accordance with the Joint Political Declaration of Member States and the Commission on explanatory documents, Member States have undertaken to accompany, only in justified cases, the notification of their transposition measures with one or more explanatory documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. Considering the limited legal obligations set by this Directive, explanatory documents from the Member States in the context of transposition of this Directive are not needed.
This initiative has no budgetary implications for the EU and requires no additional human resources in the Commission.